Health Condition 1: K754- Autoimmune hepatitis
Conditions
Interventions
Intervention1: Fecal Microbiota Transplantation plus standard of care - immunosuppression: Fresh fecal material, within 6 hours after defecation, will be used. To protect the anaerobic bacteria, the s
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age greater than equal to 18 years 2. AIH patients with insufficient response to treatment 3. AIH patients with treatment non-response (non-response to either first line immunosuppressants eg steroids, budesonide, azathioprine or non-response to subsequent second line immunosuppressants eg MMF, tacrolimus) 4. Patients with AIH, PSC, PBC or overlap syndrome (AIH-PBC, AIH-PSC) 5. Willing and able to comply with the FMT regimen and all other study requirements 6. The patient or guardian can provide written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients with active infection (Bacterial/Fungal) 2. Pregnant or breastfeeding. Women of childbearing potential will be screened with beta-human chorionic gonadotropin (ß-hCG). 3. Those with co-existent etiologies for chronic liver disease, including hepatitis C virus (HCV), HBV, alcoholic liver disease, NAFLD and Wilson disease 4. People living with HIV (PLHIV) 5. Medical conditions that require prolonged or frequent use of systemic acyclovir or famciclovir (e.g., for recurrent herpes virus infections, etc). Prolonged use means episodic treatment with these agents for 10 days every 3 months or chronic suppressive therapy. 6. History of acute decompensation of chronic liver disease (defined as jaundice, ascites, variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis) 7. Patients with acute on chronic liver failure (ACLF) 8. Patients with hepatocellular carcinoma (HCC) 9. Patients with daily alcohol consumption of more than 30 gm of ethanol or abusing illicit drugs 10. Medical conditions which require the use of potentially hepatotoxic drugs (e.g. dapsone, erythromycin, fluconazole, ketoconazole, rifampin, anti-tuberculosis regimens, others) or nephrotoxic drugs (e.g., frequent NSAIDs, aminoglycosides, amphotericin B, foscarnet). 11. Patients on warfarin or other anticoagulants for 30 days prior to screening or if expected during the present study. 12. Other concurrent medical conditions likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study (e.g., concurrent malignancies, history of unstable angina, repeated myocardial infarction or congestive heart failure, renal insufficiency, uncontrolled asthma or diabetes, unstable thyroid disease or other significant hormonal conditions, uncontrolled seizure disorders, severe psychiatric disorders, active tuberculosis under current treatment, etc 13. MELD >22
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To assess the efficacy of fecal microbiota transplantation in achieving biochemical response in AIH patients with an insufficient or non-response to standard immunosuppression (either to first or to both first and second line).Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the efficacy of FMT in achieving biochemical remission in overlap syndrome. 2.To evaluate gut microbiome composition at baseline (before FMT) and after 6 months of FMT in this cohort of patients. 3.To assess the effect of FMT on changes in the LSM values on fibroscan. 4.Safety assessment, including the incidence of clinical adverse events and incidence of laboratory abnormality after FMT 5.To evaluate the effect of FMT on serum lipopolysaccharide (LPS) levels 6.To assess the impact of FMT on the serum IgG levelTimepoint: 1. 6 months 2. 6 months 3. 6 months 4. 6 months 5. 6 months 6. 6 months | — |
Countries
India
Contacts
Public ContactDr Arnav Aggarwal
All India Institute of Medical Sciences
Outcome results
None listed